Zavation recalls 10G single cement delivery kits for orthopedic/spinal procedures due to potential inadequate sterilization. Affected kits may pose infection risks if used without proper sterilization.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling 10G single cement delivery kits used in spinal and orthopedic procedures because some kits may not have been properly sterilized. This could lead to infection risks if the kits are used without adequate sterilization.
The kits may not have been adequately sterilized, which could lead to infection if used without proper sterilization. This is a potential risk during surgical procedures where sterile conditions are critical.
Medical professionals using these kits for spinal or orthopedic procedures. Patients undergoing such surgeries are at risk if the kits are not properly sterilized.
The product is labeled '10G SINGLE CEMENT DELIVERY KIT (5 FILLERS)' for orthopedic or spinal procedures. It was distributed by Zavation and is pending recall.
Look for the label '10G SINGLE CEMENT DELIVERY KIT (5 FILLERS)' for orthopedic or spinal procedures.
The kits may not have been adequately sterilized, which could lead to infection risks if used without proper sterilization.
Check the label to confirm if you have the recalled kit. If you do, contact Zavation for further instructions.
The recall is due to potential infection risks from inadequate sterilization, not direct injury risks like cuts or fires.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1735-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1735-2021 from Zavation. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
